title: Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.
abstract: BACKGROUND
  Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND.
  
  
  METHODS
  After obtaining eIND approval from the Food and Drug Administration and local institutional review board approval, clinicians caring for hospitalized patients with influenza administered intravenous peramivir and collected information on demographic characteristics, clinical characteristics, and outcomes.
  
  
  RESULTS
  From April through October 2009, peramivir was requested for 42 patients and administered to 20 adults and 11 children. At hospitalization, all patients had rapidly progressing, radiographically confirmed viral pneumonia with respiratory failure, and all but 1 patient required mechanical ventilation. In most patients, including 1 person with documented oseltamivir-resistant infection, the illness had progressed despite oseltamivir treatment. Peramivir was administered for 1-14 days (median duration, 10 days). The 14-day, 28-day, and 56-day survival rates were 76.7%, 66.7%, and 59.0%, respectively. Peramivir was generally well tolerated.
  
  
  CONCLUSIONS
  Intravenous peramivir was well tolerated and was associated with recovery in most patients hospitalized with severe 2009 H1N1 influenza viral pneumonia and treated under an eIND.
authors.affiliation: ID Clinical Development, Clinical Pharmacology, and Clinical Development, BioCryst Pharmaceuticals, Durham, NC, USA. jhernandez@biocryst.com
authors.forename: Jaime E
authors.initials: JE
authors.lastname: Hernandez
authors.forename: Raghavendra
authors.initials: R
authors.lastname: Adiga
authors.forename: Robert
authors.initials: R
authors.lastname: Armstrong
authors.forename: Jose
authors.initials: J
authors.lastname: Bazan
authors.forename: Hector
authors.initials: H
authors.lastname: Bonilla
authors.forename: John
authors.initials: J
authors.lastname: Bradley
authors.forename: Robin
authors.initials: R
authors.lastname: Dretler
authors.forename: Michael G
authors.initials: MG
authors.lastname: Ison
authors.forename: Julie E
authors.initials: JE
authors.lastname: Mangino
authors.forename: Stacene
authors.initials: S
authors.lastname: Maroushek
authors.forename: Avinash K
authors.initials: AK
authors.lastname: Shetty
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Christine
authors.initials: C
authors.lastname: Ziebold
authors.forename: Jenna
authors.initials: J
authors.lastname: Elder
authors.forename: Alan S
authors.initials: AS
authors.lastname: Hollister
authors.forename: William
authors.initials: W
authors.lastname: Sheridan
mesh_terms: D000146:Acids, Carbocyclic; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D016638:Critical Illness; D003517:Cyclopentanes / Q000008:administration & dosage* / Q000009:adverse effects; D015507:Drugs, Investigational / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006146:Guanidines / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000188:drug therapy* / Q000401:mortality / Q000821:virology*; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000146:Acids, Carbocyclic; D000998:Antiviral Agents; D003517:Cyclopentanes; D015507:Drugs, Investigational; D006146:Guanidines; C414210:peramivir